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Hydrogen Inhalation for Health and Exercise Performance (HIHEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846141
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Novi Sad, Faculty of Sport and Physical Education

Brief Summary:
In this randomized double-blind, placebo-controlled, crossover pilot trial, we evaluated the effects of 7-day H2 inhalation on exercise performance outcomes and serum hormonal and inflammation profiles in a cohort of young men and women.

Condition or disease Intervention/treatment Phase
Exercise Performance Other: Placebo Other: Hydrogen Not Applicable

Detailed Description:
All participants were allocated to receive either gaseous hydrogen (4%) or placebo (room air) by 20-min once-per-day inhalation for 7 days, with wash-out period of 7 days to prevent the residual effects of interventions across study periods. The primary treatment outcome was the change in running time-to-exhaustion from baseline to day 7. Additionally, assessment of other exercise performance endpoints and clinical chemistry biomarkers were performed at baseline and after 7 days after each intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Hydrogen Inhalation for Health and Exercise Performance
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Room air for inhalation
Other: Placebo
Inhalation of room air for 20 min per day during 7 days

Experimental: Hydrogen
Hydrogen (4%) for inhalation
Other: Hydrogen
Inhalation of 4% hydrogen for 20 min per day during 7 days




Primary Outcome Measures :
  1. Change in exercise performance [ Time Frame: Change from baseline running time-to-exhaustion at 7 days ]
    Running time-to-exhaustion


Secondary Outcome Measures :
  1. Change in exercise performance [ Time Frame: Change from baseline maximal voluntary isometric strength at 7 days ]
    Maximal voluntary isometric strength

  2. Change in clinical chemistry biomarker [ Time Frame: Change from baseline serum insulin at 7 days ]
    Insulin

  3. Change in clinical chemistry biomarker [ Time Frame: Change from baseline serum ghrelin at 7 days ]
    Ghrelin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age ≥ 18 -35 years Body mass index 20 - 25 kg/m2 Free of major diseases Physically active Must be able to give written informed consent

Exclusion Criteria:

Use of any dietary supplements within 4 weeks before study commences Abnormal values for lab clinical chemistry (> 2 SD)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846141


Locations
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Serbia
FSPE Applied Bioenergetics Lab
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
Investigators
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Principal Investigator: Sergej Ostojic, MD, PhD University of Novi Sad
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier: NCT03846141    
Other Study ID Numbers: UniversityNSFSandPE
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will provide IPD on our University repository site

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes